Device Dossier

Arthrex® ECLIPSE™ Trunion - Shoulder prosthesis screw

Device Dossier for Arthrex® ECLIPSE™ Trunion - Shoulder prosthesis screw (Shoulder prosthesis screw, Class III, sponsor Arthrex). ARTG record, intended…

Intended purpose

The Arthrex ECLIPSE Trunion Shoulder Prosthesis is indicated as a total or hemi shoulder joint replacement where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or re-constructible for the following specific indications: Degenerative pathologies: osteoarthritis, arthritis due to instability, and idiopathic avascular humeral head necrosis Post-traumatic pathologies: post-traumatic arthritis, post-traumatic instability, and post-traumatic humeral head necrosis. It is intended for non-cemented use only.

Functional description

A sterile base stem of the Eclipse shoulder prosthesis placed in the proximal humerus, designed to limit humeral bone removal while maintaining humeral head stability.

TGA Public Summary